Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-30 @ 9:04 PM
Study NCT ID:
NCT00005635
Status:
COMPLETED
Last Update Posted:
2013-08-20
First Post:
2000-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
Sponsor:
Genentech, Inc.
Organization:
Study Overview
Official Title:
A Phase II Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of Herceptin Administered Subcutaneously in Combination With Paclitaxel in Women With HER2 Overexpressing Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of two different regimens of trastuzumab plus paclitaxel in treating women who have metastatic breast cancer that overexpresses HER2.
PURPOSE: Randomized phase II trial to study the effectiveness of two different regimens of trastuzumab plus paclitaxel in treating women who have metastatic breast cancer that overexpresses HER2.
Detailed Description:
OBJECTIVES: I. Evaluate the safety and tolerability of subcutaneous trastuzumab (Herceptin) plus paclitaxel in women with HER2 overexpressing metastatic breast cancer. II. Assess the activity of this treatment regimen in these patients. III. Determine the pharmacokinetics of trastuzumab and paclitaxel in this regimen.
OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. Patients receive a loading dose of trastuzumab (Herceptin) IV over 90 minutes followed by paclitaxel IV over 3 hours on day 0. Paclitaxel is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Arm I: Patients receive trastuzumab subcutaneously (SC) weekly starting day 7. Arm II: Patients receive trastuzumab SC twice weekly starting day 7. Treatment with trastuzumab SC continues for 48 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.
OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. Patients receive a loading dose of trastuzumab (Herceptin) IV over 90 minutes followed by paclitaxel IV over 3 hours on day 0. Paclitaxel is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Arm I: Patients receive trastuzumab subcutaneously (SC) weekly starting day 7. Arm II: Patients receive trastuzumab SC twice weekly starting day 7. Treatment with trastuzumab SC continues for 48 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: